Recruiting

Retrograde Nailing vs. ORIF

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT05131321

Conditions

Ankle Fractures

Pilon Fracture

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Primary ankle arthrodesis (fusion)

ORIF (open reduction and internal fixation)

Intramedullary Fibular Nailing (IMFN)

Study Details

Brief summary:

This will be a multi-centre randomized controlled trial, with London Health Sciences Centre (LHSC) as the lead site. Elderly patients with complex ankle fractures who meet the inclusion criteria and provide consent will be randomized (through a web-based randomization system) to one of the two treatment arms. One group (Group A) will receive primary ankle fusion, and the second group (Group B) will receive primary ankle open reduction and internal fixation (ORIF). Patient important outcomes will be compared at one year post injury

The Investigators have amended the study to include a second part for patients with less complicated but still unstable ankle fractures. In this part, patients will be randomly assigned to receive either a procedure called ORIF or another one called retrograde intramedullary fibular nailing.

Conditions

Ankle Fractures

Pilon Fracture

Study ID

NCT05131321

Start date

Apr 21, 2022

Status verified date

Mar, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Patient Inclusion Criteria - Both Parts:

(i) Age ≥ 60 years (ii) One or more of the following:

  • Severe soft tissue compromise
  • Significant co-morbidities (vascular disease + chronic trophic changes, diabetes + neuropathy, chronic renal failure, morbid obesity (BMI> 40))
  • Frailty as defined by a Dalhousie Clinical Frailty Scale score ≥4

Part 1 Specific Inclusion Criteria:

(i) Isolated fracture (within 4 weeks of injury): an AO/OTA type 43C2 or C3 tibial pilon fracture or severe ankle fracture (fracture-dislocation, severe joint impaction, severe trimalleolar)

Part 2 Specific Inclusion Criteria (i) Isolated fracture (within 4 weeks of injury): an AO/OTA type 44B2, B3, C1 or C2 ankle fracture

Patient Exclusion Criteria - Both Parts:

(i) Presence of vascular injury or pathologic fracture; (ii) Previous tibia pilon fracture or retained hardware in affected limb; (iii) Refusal to participate; (iv) Inability to obtain informed consent due to language barrier

Study Design

Enrollment

172 participants

Anticipated

Interventions and Outcome Measures

Arms

Part 1: Fusion Group

Primary arthrodesis: Subjects allocated to the fusion group will have insertion of a retrograde locked calcaneal nail. Tibiotalar joint preparation, bone grafting, subtalar preparation, and fibulectomy will not be performed unless deemed necessary by the treating surgeon.

Part 2: Fibula

Intramedullary Fibular Nailing: Participants allocated to the IMFN group will receive a locked fibular nail using a previously described technique.

Control Group: Internal Fixation

ORIF will be performed using modern techniques for timing and staging of fixation, soft tissue and fibula management, surgical approaches, reduction techniques, and plate choice.

Interventions

Primary ankle arthrodesis (fusion)

Primary arthrodesis: Subjects allocated to the fusion group will have insertion of a retrograde locked calcaneal nail. Tibiotalar joint preparation, bone grafting, subtalar preparation, and fibulectomy will not be performed unless deemed necessary by the treating surgeon.

ORIF (open reduction and internal fixation)

ORIF: ORIF will be performed using modern techniques for timing and staging of fixation, soft tissue and fibula management, surgical approaches, reduction techniques, and plate choice.

Intramedullary Fibular Nailing (IMFN)

Intramedullary Fibular Nailing: Participants allocated to the IMFN group will receive a locked fibular nail using a previously described technique.

Primary outcome measure

  • Short-Form 12 (SF-12). [ Time Frame: 1 year post-surgery. ]

Central Contacts and Locations

Central contacts

Emil Schemitsch, MD, FRCS(C)

519-663-3307emil.schemitsch@lhsc.on.ca

Abdel Lawendy, MD, FRCS(C)

519-685-8500AbdelRahman.Lawendy@lhsc.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A5W9

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Jan 28, 2026

Last verified

Mar, 2025

Keywords

  • Complex ankle fracture
  • Pilon fracture
  • Primary Ankle Arthrodesis
  • Fragility fracture
  • Elderly
  • Open reduction
  • Internal fixation
  • AO/OTA type 44B2, B3, C1 or C2 ankle fracture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2026-01-28.